BIO INSTABILITY DRILL GUIDE SERRATED C6172

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2007-02-15 for BIO INSTABILITY DRILL GUIDE SERRATED C6172 manufactured by Conmed Linvatec.

MAUDE Entry Details

Report Number1017294-2007-00082
MDR Report Key836272
Report Source01,07,08
Date Received2007-02-15
Date of Report2007-01-17
Date Mfgr Received2007-01-17
Date Added to Maude2007-04-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactBEVERLY SCHANER
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal33773
Manufacturer Phone7273995169
Manufacturer G1CONMED LINVATEC
Manufacturer Street11311 CONCEPT BLVD.
Manufacturer CityLARGO FL 33773
Manufacturer CountryUS
Manufacturer Postal Code33773
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBIO INSTABILITY DRILL GUIDE SERRATED
Generic NameDRILL GUIDE
Product CodeLXI
Date Received2007-02-15
Returned To Mfg2006-01-17
Model NumberNA
Catalog NumberC6172
Lot Number0000618A
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key823565
ManufacturerCONMED LINVATEC
Manufacturer Address* LARGO FL * US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-02-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.